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Results For "regulatory"

1134 News Found

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg
Drug Approval | August 06, 2024

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA


Roche closes acquisition of LumiraDx’s Point of Care technology
News | August 05, 2024

Roche closes acquisition of LumiraDx’s Point of Care technology

The acquisition of LumiraDx’s Point of Care technology received all required antitrust and regulatory clearances


Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers
Drug Approval | July 31, 2024

Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers

The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2


GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s  CHMP opinion for adults aged 50-59
Drug Approval | July 30, 2024

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
Drug Approval | July 24, 2024

USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau

The inspections concluded with no Form 483 observations or significant critical findings


Meitheal  acquires Contepo from Nabriva Therapeutics to expand specialty biopharmaceuticals portfolio
News | July 23, 2024

Meitheal acquires Contepo from Nabriva Therapeutics to expand specialty biopharmaceuticals portfolio

Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape


Bayer announces positive topline results for Nubeqa from Phase III trial in men with mHSPC
Diagnostic Center | July 23, 2024

Bayer announces positive topline results for Nubeqa from Phase III trial in men with mHSPC

Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT


dsm-firmenich to sell MEG-3 fish oil business to KD Pharma Group
News | July 22, 2024

dsm-firmenich to sell MEG-3 fish oil business to KD Pharma Group

dsm-firmenich decided to de-prioritize certain business segments, including the MEG-3 business